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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203993

ONFI (CLOBAZAM)
2.5MG/ML
Marketing Status: Prescription
Active Ingredient: CLOBAZAM
Proprietary Name: ONFI
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 2.5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N203993
Product Number: 001
Approval Date: Dec 14, 2012
Applicant Holder Full Name: LUNDBECK PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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